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NCT03428204: Balloon-angio
Effect of Inflation on the Angiographic Result After Balloon Angioplasty in the Femoropopliteal Segment
NA trial testing Balloon dilation during 180 seconds in Femoropopliteal Arterial Stenosis in 200 participants. Status unknown.
1 October 2019
Quick facts
| Lead sponsor | Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 28 November 2017 |
| Primary completion | 1 October 2019 |
| Estimated completion | 1 October 2019 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Balloon dilation during 180 seconds
- Balloon dilation during 300 seconds
Conditions studied
- Femoropopliteal Arterial Stenosis — all drugs for Femoropopliteal Arterial Stenosis →
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain — full company profile →
Who can join
Adults 45 to 90, any sex, with Femoropopliteal Arterial Stenosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Percutaneous angioplasty with balloon dilation is the method of choice for the treatment of most femoropopliteal artery lesions. After balloon dilatation, arterial wall dissection with flow limiting dissection or recoil with residual stenosis often require additional procedures such as stent placement or prolonged balloon dilation. A shorter balloon inflation time of 30 sec will be accompanied by a higher number of flow limiting dissection or recoil, demanding a time consuming and expensive stent placement or balloon redilatation. The effect of different balloon inflation times has only been assessed ones in peripheral balloon angioplasty with better outcomes after prolonged balloon inflation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03428204
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03428204 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Last refreshed: 11 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03428204.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing